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Biotech Stock Roundup: Puma Soars on Advisory Panel Vote, Priority Review for Kite Drug
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While Puma’s (PBYI - Free Report) shares soared on a positive recommendation from an FDA advisory panel for the company’s breast cancer treatment, neratinib, companies like Inovio (INO - Free Report) and BioCryst (BCRX - Free Report) also saw their shares gaining on positive data.
Recap of the Week’s Most Important Stories
Puma Hits 52-Week High on Favorable FDA Panel Vote: Puma’s shares touched a 52-week high last week with the company gaining the support of an FDA advisory panel for its experimental breast cancer treatment, neratinib. The FDA’s Oncologic Drugs Advisory Committee voted 12 - 4 in favor of approving neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer based on a favorable risk-benefit profile (Read more: Puma Soaring After Neratinib FDA Panel Win, Time to Buy?).
Full Marketing Approval for Biogen’s Fampyra in the EU: Biogen (BIIB - Free Report) got full marketing approval from the European Commission (EC) for Fampyra, which is indicated for walking improvement in people with multiple sclerosis (MS). Fampyra was initially given conditional marketing authorization in 2011. Fampyra is marketed in the U.S. by Acorda under the trade name Ampyra (Read more: Biogen's Fampyra Conditional Approval Converted to Standard).
Kite Drug Gets Priority Review: Kite gained priority review for its regulatory application for its lead pipeline candidate, axicabtagene ciloleucel, with the FDA expected to respond on the approval status of the CAR-T treatment by Nov 29, 2017. Kite is looking to get axicabtagene ciloleucel approved for use in patients with refractory aggressive non-Hodgkin lymphoma (NHL). There is urgent medical need for this patient population with these patients facing only a 50% chance of surviving six months. The European marketing application for axicabtagene ciloleucel is slated for submission in the third quarter (Read more: Kite Pharma Cancer Drug BLA Gets Priority Review Status).
Inovio Up on HIV Data: Inovio’s HIV vaccine, Pennvax-GP, showed promising results in a study with the investigational vaccine achieving almost 100% immune response rates. This is amongst the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine. Inovio’s shares shot up 21.7% on the data.
BioCryst HAE Drug Impresses in Second Interim Analysis: BioCryst’s shares were also up on results from a second interim analysis of the company’s phase II study on BCX7353 for hereditary angioedema (HAE). The company said that a once-daily 125 mg dose of BCX7353 showed a high level of efficacy with an improved tolerability profile compared to the 350 mg dose observed in the first interim analysis. BioCryst is now looking to complete Part 3 of the study and select suitable doses for its pivotal program.
FDA Panel Supports Pfizer’s Biosimilar Version of Amgen’s Epogen: Pfizer, which is making a biosimilar version of J&J’s Procrit and Amgen’s Epogen (epoetin alfa), got a favorable vote from the FDA’s Oncologic Drugs Advisory Committee (ODAC) across all indications. This is the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by an FDA advisory panel. While the FDA is not required to do so, it usually follows the recommendation of its advisory panels. Although Epogen sales have been declining, it contributed $1.3 billion to Amgen’s total revenues in 2016.
YTD, Amgen has performed better than the Zacks-categorized Medical-Biomedical/Genetics industry with the company gaining 6% while the industry is down 0.3%.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined 1% over the last four trading sessions. Among major biotech stocks, Amgen gained 1.3% while Alexion lost 15.4%. Over the last six months, Vertex was up 36.6% while Biogen and Alexion were down 17.8% (See the last biotech stock roundup here: FDA Nod for Regeneron RA Drug, Amgen Hit by Study Data).
What's Next in the Biotech World?
Companies like Amgen, Celgene and AbbVie (ABBV - Free Report) will all be at the annual meeting of the American Society of Clinical Oncology (ASCO) showcasing data on approved and pipeline candidates targeting cancer.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>
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Biotech Stock Roundup: Puma Soars on Advisory Panel Vote, Priority Review for Kite Drug
While Puma’s (PBYI - Free Report) shares soared on a positive recommendation from an FDA advisory panel for the company’s breast cancer treatment, neratinib, companies like Inovio (INO - Free Report) and BioCryst (BCRX - Free Report) also saw their shares gaining on positive data.
Recap of the Week’s Most Important Stories
Puma Hits 52-Week High on Favorable FDA Panel Vote: Puma’s shares touched a 52-week high last week with the company gaining the support of an FDA advisory panel for its experimental breast cancer treatment, neratinib. The FDA’s Oncologic Drugs Advisory Committee voted 12 - 4 in favor of approving neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer based on a favorable risk-benefit profile (Read more: Puma Soaring After Neratinib FDA Panel Win, Time to Buy?).
Puma’s shares are up 159.8% year-to-date (YTD) with a major part of this gain (96.4%) being recorded over the past one month. Puma is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Full Marketing Approval for Biogen’s Fampyra in the EU: Biogen (BIIB - Free Report) got full marketing approval from the European Commission (EC) for Fampyra, which is indicated for walking improvement in people with multiple sclerosis (MS). Fampyra was initially given conditional marketing authorization in 2011. Fampyra is marketed in the U.S. by Acorda under the trade name Ampyra (Read more: Biogen's Fampyra Conditional Approval Converted to Standard).
Kite Drug Gets Priority Review: Kite gained priority review for its regulatory application for its lead pipeline candidate, axicabtagene ciloleucel, with the FDA expected to respond on the approval status of the CAR-T treatment by Nov 29, 2017. Kite is looking to get axicabtagene ciloleucel approved for use in patients with refractory aggressive non-Hodgkin lymphoma (NHL). There is urgent medical need for this patient population with these patients facing only a 50% chance of surviving six months. The European marketing application for axicabtagene ciloleucel is slated for submission in the third quarter (Read more: Kite Pharma Cancer Drug BLA Gets Priority Review Status).
Inovio Up on HIV Data: Inovio’s HIV vaccine, Pennvax-GP, showed promising results in a study with the investigational vaccine achieving almost 100% immune response rates. This is amongst the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine. Inovio’s shares shot up 21.7% on the data.
BioCryst HAE Drug Impresses in Second Interim Analysis: BioCryst’s shares were also up on results from a second interim analysis of the company’s phase II study on BCX7353 for hereditary angioedema (HAE). The company said that a once-daily 125 mg dose of BCX7353 showed a high level of efficacy with an improved tolerability profile compared to the 350 mg dose observed in the first interim analysis. BioCryst is now looking to complete Part 3 of the study and select suitable doses for its pivotal program.
FDA Panel Supports Pfizer’s Biosimilar Version of Amgen’s Epogen: Pfizer, which is making a biosimilar version of J&J’s Procrit and Amgen’s Epogen (epoetin alfa), got a favorable vote from the FDA’s Oncologic Drugs Advisory Committee (ODAC) across all indications. This is the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by an FDA advisory panel. While the FDA is not required to do so, it usually follows the recommendation of its advisory panels. Although Epogen sales have been declining, it contributed $1.3 billion to Amgen’s total revenues in 2016.
YTD, Amgen has performed better than the Zacks-categorized Medical-Biomedical/Genetics industry with the company gaining 6% while the industry is down 0.3%.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined 1% over the last four trading sessions. Among major biotech stocks, Amgen gained 1.3% while Alexion lost 15.4%. Over the last six months, Vertex was up 36.6% while Biogen and Alexion were down 17.8% (See the last biotech stock roundup here: FDA Nod for Regeneron RA Drug, Amgen Hit by Study Data).
What's Next in the Biotech World?
Companies like Amgen, Celgene and AbbVie (ABBV - Free Report) will all be at the annual meeting of the American Society of Clinical Oncology (ASCO) showcasing data on approved and pipeline candidates targeting cancer.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>